Ireland· IE-PA-EU/1/12/760/001-002
Bronchitol 40 mg inhalation powder, hard capsules
A mannitol product containing mannitol, registered in Ireland by Pharmaxis Europe Limited. The same ATC class is registered in 11 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Mannitol is registered in 11 of 19 countries.
Countries holding a registration under ATC R05CB16 (mannitol), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 6 of them publish a price we can compare per daily dose
Mannitol · ATC R05CB16
11 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Germany
- Icelandprice
- Ireland
- Netherlands
- Polandprice
- United Kingdom
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Mannitol
- Manufacturer
- Pharmaxis Europe Limited
- Country
- Ireland (IE)
- ATC code
- R05CB16
- ATC class
- Mannitol
- Defined daily dose
- 0.8 g, Inhal
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/12/760/001-002
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
304 interactions on record for mannitol.
Graded by severity as the source publishes them — 14 severe. Severity grades are free for everyone; mechanism and management come with Growth.
- Severity for every pair — free, no plan needed
- The source, licence and sync date on every record
- Mechanism and what to do for each pair — Growth plan
Mannitol · interactions on record
304 records
- 14 severe
- 104 moderate
- 5 minor
- 181 info
Most severe, free to view
- NeomycinA07AA01severe
- StreptomycinA07AA04severe
- KanamycinA07AA08severe
- NeomycinB05CA09severe
- Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Same medicine, other countries
Mannitol in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomBronchitol 40mg inhalation powder capsules with deviceChapper Healthcare
- CzechiaBRONCHITOLPharmaxis Europe Limited, Dublin
- FinlandBronchitolPharmaxis Europe Limited
- IcelandBronchitolPharmaxis Europe Limited
- NetherlandsBronchitol 40 mg inhalatiepoeder, harde capsulesPharmaxis Europe Limited
- PolandBronchitolPharmaxis Europe Limited
- BelgiumBronchitol 40 mgPharmaxis Europe
- SwedenBronchitol 40 mg Inhalationspulver, hård kapselPharmaxis Europe Limited
Authorised across Europe · EMA
The same active substance is authorised in 30 EEA countries. Names it is sold under:
- Austria · Mannit Fresenius
- Belgium · Mannitol Viaflo Baxter, Mannitol, Viaflo Baxter
- Bulgaria · Манитол Б. Браун, Манитол Бакстер
- Cyprus · Mannitol Demo, Mannitol Βιοσερ
- Czechia · Ardeaosmosol Ma, Manitol Viaflo Baxter
- Germany · Aridol, Mannit-Lösung Serag
- Denmark · Mannitol Fresenius Kabi, Osmohale
- Estonia · Mannitol Fresenius
- Spain · Manitol Mein, Osmofundina
- Finland · Aridol, Mannitol Braun
- France · Mannitol Aguettant, Mannitol B. Braun
- United Kingdom (Northern Ireland) · Mannitol Baxter Healthcare, Osmohale
- Greece · Mannitol Bradex, Mannitol Cooper
- Croatia · Manitol Hztm
- Hungary · Mannisol A, Mannisol B
- Iceland · Bronchitol, Mannitol Viaflo Baxter
- Italy · Mannitolo Bioindustria L.I.M, Mannitolo Bioindustria L.I.M.
- Liechtenstein · Bronchitol
- Lithuania · Mannitol Fresenius
- Luxembourg · Mannitol Viaflo, Mannitol Viaflo Baxter
- Latvia · Mannitol Fresenius
- Malta · Mannitol Baxter Holding, Mannitol Monico
- Netherlands · Mannitol Baxter, Osmohale
- Norway · Aridol, Bronchitol
- Poland · Mannitol Baxter, Mannitol Fresenius
- Portugal · Manitol Braun, Manitol Labesfal
- Romania · Manitol Infomed Fluids, Mannitol Vioser
- Sweden · Aridol, Mannitol Fresenius Kabi
- Slovenia · Manitol Hztm
- Slovakia · Infusio Mannitoli, Mannitol Bieffe
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of HPRA (Ireland). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/d43696d3-f9eb-4b7a-bc59-bf10cd3b61cf GET /v1/drugs/d43696d3-f9eb-4b7a-bc59-bf10cd3b61cf?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"form": "Inhalation powder, hard capsule",
"routes": [
"Inhalation use"
],
"source": "hpra",
"atc_all": [
"R05CB",
"R05CB16"
],
"strength": null,
"pa_number": "EU/1/12/760/001-002",
"substances": [
"Mannitol"
],
"legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "26/09/2012",
"dispensing_status": "Product subject to prescription which may not be renewed (A)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}See everything about mannitol.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.